FDA Adverse Event Malfunction Summary report: N

PRODISC-L SUP-PL SIZ L 3°

MDR report key: 3222706 · Received July 12, 2013

Report

Report Number: 8030965-2013-04286
Event Type: Malfunction
Date Received: July 12, 2013
Report Date: June 14, 2013
Manufacturer: SYNTHES GMBH
Product Code: MJO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Additional Manufacturer Narrative · 1

THE INVESTIGATION OF THE COMPLAINED PRODISC-L PACKAGING SHOWS A STICKING OF THE INNER AND OUTER COVER. THE STICKING OF BOTH TYVEK LIDDING FILMS IS NOT PROPOSED. WE ASSUME THAT DURING THE SEALING PROCEDURE OF THE BOTH TYVEK LIDDING FILMS WERE COMPRESSED SUCH STRONG THAT THE RESULT OF THIS WAS THE STICKING OF THIS LIDDING FILMS. BECAUSE THE INNER TYVEK WAS COMING CLOSE TO THE SEALING SEAM, BOTH LIDDING FILMS WERE STICKING TOGETHER. TO REACH A PRODUCT IMPROVEMENT, WE ALREADY OPTIMIZE THE PACKAGING TO AVOID THIS FAILURE IN THE FUTURE. THE PREVIOUS LOT WAS MANUFACTURED IN JULY 2012, WHICH WAS BEFORE WE HAVE DONE THE IMPROVEMENTS OF THIS PRODUCT. THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PLACEHOLDER.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS NOTED ON AN UNKNOWN DATE THAT THE PACKAGING IS NOT IN GOOD ORDER. AT THE INBOARD PACKAGING UNIT THE FILM IS DIVIDED AND COULD NOT BE OPENED CORRECTLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
321908	PRODISC-L SUP-PL SIZ L 3°		MJO	SYNTHES GMBH		7936937

Patients

Seq	Age	Sex	Outcome	Treatment
1